XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP


Device Classification Name

laparoscope, gynecologic (and accessories)

510(k) Number K022384
Device Name XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
Original Applicant
ISOLUX AMERICA
1479 railhead blvd.
naples, 
FL 
34110 -8444

Original Contact nikolaos andreoulakis
Regulation Number 884.1720
Classification Product Code
HET  
Date Received 07/22/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No